ALL SILICONE FOLEY BALLOON CATHETER

GUDID 08806369400527

2way/Green 30cc 16fr

Sewoon Medical Co., Ltd.

Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 08806369400527
• NIH Device Record Key: dd3bb259-fb0c-40c0-bc95-e04ff2c5b415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALL SILICONE FOLEY BALLOON CATHETER
• Version Model Number: 2102-516
• Company DUNS: 687784405
• Company Name: Sewoon Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806369400527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013276

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [ALL SILICONE FOLEY BALLOON CATHETER]

• 08806369403603: 3way//Translucent 30cc 26fr
• 08806369403108: 3way//Translucent 5cc 26fr
• 08806369403085: 3way//Translucent 5cc 24fr
• 08806369403061: 3way//Translucent 5cc 22fr
• 08806369403047: 3way//Translucent 5cc 20fr
• 08806369403023: 3way//Translucent 5cc 18fr
• 08806369403009: 3way//Translucent 5cc 16fr
• 08806369402620: 2way/Translucent 30cc 26fr
• 08806369402606: 2way/Translucent 30cc 24fr
• 08806369402583: 2way/Translucent 30cc 22fr
• 08806369402569: 2way/Translucent 30cc 20fr
• 08806369402545: 2way/Translucent 30cc 18fr
• 08806369402521: 2way/Translucent 30cc 16fr
• 08806369402507: 2way/Translucent 30cc 14fr
• 08806369402002: 2way/Translucent 1.5cc 6fr
• 08806369400626: 2way/Green 30cc 26fr
• 08806369400602: 2way/Green 30cc 24fr
• 08806369400589: 2way/Green 30cc 22fr
• 08806369400565: 2way/Green 30cc 20fr
• 08806369400541: 2way/Green 30cc 18fr
• 08806369400527: 2way/Green 30cc 16fr
• 08806369400503: 2way/Green 30cc 14fr
• 08806369400008: 2way/Green 1.5cc 6fr